1、Trial sites are under unsustainable pressure.Five steps can help pharma companies provide relief while building competitive advantage.By Jackie Flanagan and Jason EversHow Customer-First Clinical Trials Cut Complexity and DelaysCopyright 2023 Bain&Company,Inc.All rights reserved.1How Customer-First

2、Clinical Trials Cut Complexity and DelaysAt a Glance Rapid innovation has had the unintended consequence of burgeoning complexity for clinical trial sites,with 56%reporting that complexity has increased from three years ago,according to a Bain survey.Today,53%of sites say they lack the bandwidth to

3、run trials,up from 14%before the pandemic.Piecemeal trial solutions promise improvements that are misaligned with sites actual experience.With five principles,pharma companies can design next-gen trials that reduce delays,build competitive advantage,and bring critical innovation to patients.A new dr

4、ugs mechanism-of-action exclusivity often lasts only half as long as in the early 2000s,fueling pharmaceutical stakeholders calls for accelerated trial timelines.Capture rates are now staggering,often representing 10%to 20%of all patients.At the same time,53%of clinical trial sites say they have ins

5、ufficient bandwidth to support their current phase 2 or 3 trials,according to a Bain survey.And 56%say complexity has increased from just three years ago(see Figure 1).Behind that complexity is a surge of immense potential.Innovation and breakthrough designations are on the rise.FDA approvals nearly

6、 doubled between 2010 and 2020,including those in critical cell and gene therapies.Pharma companies are pursuing narrower and more specific indications with increasingly complex drugs,promising relief to patientsif sites can carry out more and more complicated trials.Beyond scientific complexity,ope

7、rations are progressing too,as decentralization and digital tools usher in the future of clinical trialsone of expanded patient pools and virtual interaction.Its a vicious cycle:Rapid innovation begets complexity,and unmanaged complexity stymies innovation.As a result,more than 1 in 5 trials are del

8、ayed by more than 40%of their original timelines.Sites are being forced to make tough trade-offs and turn down trials.Pharma companies are falling short on other key targets as well.For instance,80%of sponsors say they arent meeting their diversity,equity,and inclusion(DEI)goals.The numbers cast a h

9、arsh light on the challenges that sponsors,contract research organizations(CROs),and sites have been grappling with even before the pandemic.Clinical trials are buckling under the pressure.If left unchecked,the current ecosystem will hinder the pharma industrys ability to bring groundbreaking and ne

10、cessary treatments to patients.To unleash a wave of life-changing innovation,sponsors and CROs will need to tackle fundamental issues with both trial design and delivery,starting by developing a true understanding of site and patient needs.Our recent survey and expert interviews reveal that sponsors

11、 and CROs investments 2How Customer-First Clinical Trials Cut Complexity and DelaysFigure 1a:Clinical trials are facing an unsustainable confluence of challengesSource:Bain Clinical Trials Voice of Customer Survey,2022(n=95)Trial sponsors must Trial sites are facing50%deliver in less time40%and recr

12、uit more patients53%a lack of resources56%and more complex trialsdecrease in mechanism-of-actionexclusivity for the first drug to launchDown four years(201620)fromeight years(200004)more patient trial slots in oncology,compared with 201621Capture rates are often 10%20%of all patientsof sites surveye

13、d report insufficientbandwidth to run trialsCompared with 14%preCovid-19and 47%at the height of Covid-19of sites say trials are more complexthan three years agoMore than a 100%increase in thoseciting complexity from next-gen toolsand third-party vendorsFigure 1b:Clinical trials are facing an unsusta

14、inable confluence of challengesSource:Bain Clinical Trials Voice of Customer Survey,2022(n=95)Resulting in 22%significant delays80%unmet goalsof trials are delayed by more than 40%For a trial that required two years forrecruiting,the timeline is extended bymore than one year of sponsors say they are

15、nt meetingtheir DEI goalsBut more than 60%of sponsors saydiversity is very important3How Customer-First Clinical Trials Cut Complexity and Delaysare largely misaligned with sites actual experiences and pain points.So long as this disillusionment remains,so will the trial delays and frustrations.Expe

16、ctations vs.realityAs the race to market picked up in recent years,sponsors and CROs have pushed to increase the number of trial sites and boost patient recruitment.Theyve invested in a patchwork of solutions for hybrid trials,such as third-party patient recruitment vendors,wearable devices,and elec

17、tronic patient-reported outcomes.These moves toward decentralization add valuebut at a high cost.The lack of a comprehensive,integrated solution proliferates unbridled complexity that drags on the site and patient experience.And these investments havent addressed sites biggest concerns.While most sp

18、onsors are focused on traditional topline results,most sites are struggling with upstream challenges to starting up trials.For instance,when citing their top three concerns,58%of sites note institutional review board approval,44%point to the contracting and activation process,and 40%indicate accessi

19、ng and managing multiple sponsor systems(see Figure 2).Its evident that theres a mismatch between what trial solutions tout and what sites truly experience throughout the clinical trials journey.Figure 2:Sponsors and trial sites arent aligned on top challengesPreparing site beforestarting patient en

20、rollmentAccessing and managingmultiple sponsor systemsContracting andactivation processSite institutional reviewboard approvalPatient recruitment(meeting sponsorexpectations)33%40%40%44%58%Note:Sites,sponsors,and contract research organizations were asked,“Which of the following do you find most cha

21、llenging in managing individualphase 2 or 3 clinical trials?”Sources:Bain Clinical Trials Voice of Customer Survey,2022(n=95);market participant interviews Percentage of sponsors and CROs that rank thesethemes as a top three challengePercentage of trial sites that rank these themes asa top three cha

22、llengePatient recruitmentIdentifying andselecting sitesContracting andactivation processTrial budgetingPreparing sitesbefore startingpatient enrollmentSite institutional reviewboard approval49%44%31%20%19%19%4How Customer-First Clinical Trials Cut Complexity and Delays Sponsors expectation:Seamless,

23、remote site activation.Sites reality:Sites also want remote site contracting and start-up.But multiple stakeholders from the sponsor and the CRO are typically involved in activation,without a clear point of contact.Sites and CROs find themselves caught in back-and-forth emails for multiple rounds of

24、 negotiation,with no clear end in sight.Sponsors expectation:Remote training at the physician investigators discretion.Sites reality:Sites want rapid training,responses to questions,and issue resolution for investigators.But training material is typically dense.Information is spread across multiple

25、portals and data sources.And with the rise of remote monitoring,its more difficult for investigators to engage representatives.Sponsors expectation:A steady flow of qualified patients identified with advanced analytics or recruited through outsourced support.Sites reality:Sites are interested in new

26、 digital sources to identify patients,such as automated electronic medical record review or digital marketing.But the current flow of inbound referrals can be choppy.It often starts with an overwhelming deluge of qualified and unqualified patients that takes too much time to sift through,resulting i

27、n high screening failure rates.Even when the flow is steady,there typically isnt an integrated system to manage incoming patient referrals and track them through randomization,when needed.Sponsors expectation:Remote monitoring of patients at physicians discretion,with greater ap-pointment flexibilit

28、y and fewer logistical burdens.Sites reality:Sites want advanced analytics capabilities,as well as passive and automated data collection,to monitor ongoing studies.But providers find themselves burdened with learning new digital monitoring tools,training patients on the tools,interacting with patien

29、ts across several unintegrated platforms,and troubleshooting system issues.Sponsors expectations:Expanded site footprints that reach different cities and rural areas to advance DEI goals.Sites reality:While expanding site footprints and physician outreach is a critical endeavor,the current complexit

30、y often requires infrastructure beyond many underserved sites capabilities.Community sites are usually coping with less resources than larger centers.Until sponsors mitigate complexity,these efforts may have the unintended effect of hindering patient recruitment.Sites are understandably frustrated a

31、s these pain points go unaddressed.According to our survey,the number of sites reporting complexity due to decentralization has increased 120%from three years ago.Those that note complexity related to digital tools is up 111%.Adding third parties to the mix often seems to be doing more harm than goo

32、d.Given the need for increased coordination,sites citing third-party vendors as a source of complexity has doubled.And sponsors arent happy with the outcome either.Only 13%say that outsourced patient recruitment support adds significant value.5How Customer-First Clinical Trials Cut Complexity and De

33、laysThe competitive advantage of customer experienceThe timing of these piecemeal structural changes and injection of new digital tools has only added to the strain on sites.While sponsor and CRO staffing levels havent bounced back to prepandemic levels,the situation has improved since 2021.Sites,ho

34、wever,are reaching a breaking point due to high staff turnover and difficulty finding qualified candidates.More than half report insufficient bandwidth to support phase 2 and 3 trials,up from 14%before the pandemic and 47%at the height of Covid-19.Under the pressure of labor shortages,sites are beco

35、ming increasingly selective in which trials they take on,making difficult calls to close trials,and charging more for remote trials.As the competition for sites escalates,the investigator experience is becoming a powerful source of advantage.Bain research shows that investigators who have a good exp

36、erience with a sponsor enroll twice as many patients than those who have a neutral or negative experience.Pharma companies cant afford to take a wait-and-see approach.And creating an industry-leading trial experience will require more than the quickly deployed,poorly integrated point solutions of th

37、e past.Thus,theres a major benefit in catering to sites wants and needs and building investigator loyaltynamely,faster trials.Pharma companies cant afford to take a wait-and-see approach.And creating an industry-leading trial experience will require more than the quickly deployed,poorly integrated p

38、oint solutions of the past.Transforming trialsFuture winners will take a proactive,customer-first approach to transform trials end-to-end.While overhauling the system from design to delivery is a daunting task,the current model is unsustainable,and the situation will likely worsen as issues continue

39、 to compound.But five principles can help pharma companies construct a seamless trial experience.Instill a customer mindset and culture underpinned by collaboration.Leaders will prioritize holistic organizational change,oriented around a best-in-class patient and site experience.Theyll ensure collab

40、oration across all functions and partners by questioning existing silos.These companies will also clearly communicate each functions role in delivering a superior customer experience and managing complexity.6How Customer-First Clinical Trials Cut Complexity and DelaysZero-base trial design with hard

41、 trade-offs around complexity.The best trials will be fit-for-purpose,with every design element,from scientific to operational factors,determined by putting specific site and patient needs first.The key to real,lasting change is a commitment to making hard trade-offs.Leaders will push back on comple

42、xity created by nice-to-have solutions,while finding ways to mitigate customer challenges that stem from necessary scientific complexity.Reinvent the front line.For the front line to work together as a unified team,members will need the right training,support,and tools.Leadership teams can focus on

43、more disciplined account management,deeper site relationships,and the empowerment to solve challenges creatively.After taking these approaches with site monitors and medical affairs team members,one leading pharma company saw sustained increases in site engagement and subsequent enrollment.Design a

44、best-in-class site experience.Leading companies will collect routine,recurring feedback from sites and investigators.Theyll make real-time updates to integrate what they learn into the tools,processes,and technology that they deploy consistently across sites.Invest in supporting infrastructure.Winne

45、rs are getting ahead with proactive investments in performance management,from comprehensive dashboards to cross-functional customer relationship management tools for sites and investigators.For instance,one company built out end-to-end dash-boards for everyone from the front line to the C-suite to

46、monitor trial performance and make real-time adjustments in activities and resources.It also created an integrated frontline account management software used by all site-facing stakeholders on medical affairs and clinical teams to provide site-level analytics,account planning and tracking,and report

47、ing on issue resolution.Whether developing a bespoke platform or selecting one of the many emerging options for clinical trial services,leading companies will tailor their performance management to the needs of their organization,their sites,and their vendors.Whether developing a bespoke platform or

48、 selecting one of the many emerging options for clinical trial services,leading companies will tailor their performance management to the needs of their organization,their sites,and their vendors.As difficult and complex as it can be,theyll invest in unified portals and data systems that are as inte

49、grated as possible,rather than fragmented solutions.Its critical for the tools to come together seamlessly across people and processes to achieve their full value and transform clinical trials.7How Customer-First Clinical Trials Cut Complexity and DelaysTo start addressing issues head on,pharma comp

50、anies can launch redesign pilots for high-priority assets and programs.Theyll need to bring together the right stakeholders early in trial designnot later during trial deliveryto discuss issues,commit to trade-offs,and creatively address trial needs in the most seamless,least complex way possible.As

51、 this team tests and learns,it can scale the best processes and capabilities across the organization.This transformative approach will go beyond reducing delays to increase speed to market,build competitive advantage,and bring critical innovations to the patients that need them.8How Customer-First C

52、linical Trials Cut Complexity and DelaysBold ideas.Bold teams.Extraordinary results.Bain&Company is a global consultancy that helps the worlds most ambitious change makers define the future.Across 65 cities in 40 countries,we work alongside our clients as one team with a shared ambition to achieve e

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